DESCRIPTION

Chemically, carisoprodol is (+)-2-Methyl-2-propyl-1,3-propanediol carbamate
isopropylcarbamate. Carisoprodol is a white, crystalline powder, having a mild,
characteristic odor and a bitter taste. It is very slightly soluble in water;
freely soluble in alcohol, in chloroform, and in acetone. Its molecular formula
is C12H24N204, with a molecular weight of 260.34.
The structural formula is:

Chemically, aspirin is salicylic acid acetate. It can appear as white crystals,
commonly tabular or needle-like, or white crystalline powder. It is odorless or
has a faint odor. It is slightly soluble in water; freely soluble in alcohol;
soluble in chloroform and in ether; sparingly soluble in absolute ether. Its
molecular formula is C9H804, with a molecular weight of 180.16. The structural formula
is:

CLINICAL PHARMACOLOGY

Carisoprodol: Carisoprodol is a
centrally-acting muscle relaxant that does not directly relax tense skeletal
muscles in man. The mode of action of carisoprodol in relieving acute muscle
spasm of local origin has not been clearly identified, but may be related to its
sedative properties. In animals, carisoprodol has been shown to produce muscle
relaxation by blocking interneuronal activity and depressing transmission of
polysynaptic neurons in the spinal cord and in the descending reticular
formation of the brain. The onset of action is rapid and lasts four to six
hours.

Carisoprodol is metabolized in the liver and is excreted by the kidneys. It
is dialyzable by peritoneal and hemodialysis.

Aspirin:Aspirin is a nonnarcotic analgesic
with antiinflammatory and antipyretic activity. Inhibition of prostaglandin
biosynthesis appears to account for most of its antiinflammatory and for at
least part of its analgesic and antipyretic properties.

Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid
following oral administration. Although aspirin has a half-life of only about 15
minutes, the apparent biologic half-life of salicylic acid in the therapeutic
plasma concentration range is between 6 and 12 hours. Salicylic acid is
eliminated by renal excretion and by biotransformation to inactive metabolites.
Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions)and is reduced by renal dysfunction.

INDICATIONS AND USAGE

Carisoprodol and Aspirin Tablets are indicated as an adjunct to rest, physical
therapy, and other measures for the relief of pain, muscle spasm, and limited
mobility associated with acute, painful musculoskeletal conditions.

CONTRAINDICATIONS

WARNINGS

On very rare occasions, the first dose of carisoprodol has been
followed by an idiosyncratic reaction with symptoms appearing within minutes or
hours. These may include extreme weakness, transient quadriplegia, dizziness,
ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation,
euphoria, confusion, and disorientation. Although symptoms usually subside over
the course of the next several hours, discontinue Carisoprodol and Aspirin
Tablets and initiate appropriate supportive and symptomatic therapy, which may
include epinephrine and/or antihistamines. In severe cases, corticosteroids may
be necessary. Severe reactions have been manifested by asthmatic episodes,
fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and
anaphylactoid shock.

The effects of carisoprodol with agents such as alcohol, other CNS
depressants, or psychotropic drugs may be additive. Appropriate caution should
be exercised with patients who may take one or more of these agents
simultaneously with Carisoprodol and Aspirin Tablets.

PRECAUTIONS

General

To avoid excessive accumulation of carisoprodol, aspirin, or
their metabolites, use Carisoprodol and Aspirin Tablets with caution in patients
with compromised liver or kidney function, or in elderly or debilitated patients
(see CLINICAL PHARMACOLOGY).

Use with caution in patients with history of gastritis or peptic ulcer, in
patients on anticoagulant therapy, and in addiction-prone individuals.

Information for Patients

Caution patients that this drug may impair the mental and/or
physical abilities required for the performance of potentially hazardous tasks
such as driving a motor vehicle or operating machinery.

Caution patients with a predisposition for gastrointestinal bleeding that
concomitant use of aspirin and alcohol may have an additive effect in this
regard.

Caution patients that dosage of medications used for gout, arthritis, or
diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions).

Drug Interactions

Clinically important interactions may occur when certain drugs
are administered concomitantly with aspirin or aspirin-containing drugs.

8. Corticosteroids-salicylate plasma levels may be
decreased when adrenal corticosteroids are given, and may be increased
substantially when they are discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been done with Carisoprodol and Aspirin Tablets.

Pregnancy

Teratogenic Effects

Pregnancy Category C.Adequate
animal reproduction studies have not been conducted with Carisoprodol and
Aspirin Tablets. It is also not known whether Carisoprodol and Aspirin Tablets
can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Carisoprodol and Aspirin Tablets should be given to a
pregnant woman only if clearly needed. Studies in rodents have shown salicylates
to be teratogenic when given in early gestation, and embryocidal when given in
later gestation in doses considerably greater than usual therapeutic doses in
humans. Studies in women who took aspirin during pregnancy have not demonstrated
an increased incidence of congenital abnormalities in the offspring.

Labor and Delivery

Ingestion of aspirin near term or prior to delivery may prolong delivery or lead
to bleeding in mother, fetus, or neonate.

Nursing Mothers

Carisoprodol is excreted in human milk in concentrations two-to-four times that
in maternal plasma. Aspirin is excreted in human milk in moderate amounts and
can produce a bleeding tendency in nursing infants. Because of the potential for
serious adverse reactions in nursing infants a decision should be made whether
to discontinue nursing or the drug, taking into account the importance of the
drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of twelve have not
been established.

ADVERSE REACTIONS

The following side effects which have occurred with the administration of the
individual ingredients alone may also occur with the combination.

Carisoprodol:

Central Nervous System: Drowsiness is the most
frequent complaint and along with other CNS effects may require dosage
reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor,
agitation, irritability, headache, depressive reactions, syncope and insomnia
have been infrequent or rare.

Idiosyncratic: Idiosyncratic reactions are very rare.
They are usually seen within the period of the first to fourth dose in patients
having had no previous contact with the drug (see WARNINGS).

Hematologic: No serious blood dyscrasias have been
attributed to carisoprodol alone.

Leukopenia and pancytopenia have been reported, very rarely, in situations in
which other drugs or viral infections may have been responsible.

Aspirin:

The most common adverse reactions associated with the use of aspirin have
been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding,
constipation and diarrhea. Gastric erosion, angioedema, asthma rash, pruritus
and urticaria have been reported less commonly. Tinnitus is a sign of high serum
salicylate levels (see OVERDOSAGE).

Aspirin Intolerance: Allergic type reactions in
aspirin-sensitive individuals may involve the respiratory tract or the skin.
Symptoms of the former range from rhinorrhea and shortness of breath to severe
asthma, and the latter may consist of urticaria, edema, rash or angioedema
(giant hives). These may occur independently or in combination.

DRUG ABUSE AND DEPENDENCE

Abuse: In clinical use, abuse has been
rare.

Dependence: In clinical use, dependence with
Carisoprodol and Aspirin Tablets have been rare and there have been no reports
of significant abstinence signs, nevertheless, the following information on the
individual ingredients should be kept in mind.

Carisoprodol: In dogs, no withdrawal symptoms
occurred after abrupt cessation of carisoprodol from dosages as high as 1
gm/kg/day. In a study in man, abrupt cessation of 100 mg/kg/day (about five
times the recommended daily adult dosage) was followed in some subjects by mild
withdrawal symptoms such as abdominal cramps, insomnia, chills, headache and
nausea. Delirium and convulsions did not occur (see PRECAUTIONS).

OVERDOSAGE

Signs and Symptoms: Any of the following
which have been reported with the individual ingredients may occur and may be
modified to a varying degree by the effects of the other ingredients present in
Carisoprodol and Aspirin Tablets.

Carisoprodol: Stupor, coma, shock, respiratory
depression and very rarely, death. Overdosage with carisoprodol in combination
with alcohol, other CNS depressants, or psychotropic agents can have additive
effects, even when one of the agents has been taken in the usually recommended
dosage.

Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at
plasma levels above 50 mg/dl. These respiratory changes eventually lead to
serious acid-base disturbances, Metabolic acidosis is a constant finding in
infants but occurs in older children only with severe poisoning; adults usually
exhibit respiratory alkalosis initially and acidosis terminally.

Other symptoms of severe salicylate poisoning include hyperthermia,
dehydration, delirium and mental disturbances. Skin eruptions, GI hemorrhage, or
pulmonary edema are less common.

Early CNS stimulation is replaced by increasing depression, stupor, and coma.
Death is usually due to respiratory failure or cardiovascular collapse.

Treatment:

General: Provide symptomatic and supportive
treatment, as indicated. Any drug remaining in the stomach should be removed
using appropriate procedures and caution to protect the airway and prevent
aspiration, especially in the stuporous or comatose patient. Incomplete gastric
emptying with delayed absorption of carisoprodol has been reported as a cause
for relapse. Should respiration or blood pressure become compromised,
respiratory assistance, central nervous system stimulants and pressor agents
should be administered cautiously as indicated.

Carisoprodol: The following have been used
successfully in overdosage with the related drug meprobamate: diuretics, osmotic
(mannitol) diuresis, peritoneal dialysis, and hemodialysis (see CLINICAL
PHARMACOLOGY). Careful monitoring of urinary output is necessary and caution
should be taken to avoid overhydration. Carisoprodol can be be measured in
biological fluid by gas chromatography (Douglas, J.F., et al: J Pharm Sci 58:145, 1969).

Aspirin: Since there are no specific antidotes for
salicylate poisoning, the aim of treatment is to enhance elimination of
salicylate and prevent or reduce further absorption; to correct any fluid
electrolyte or metabolic imbalance; and to provide general and cardiorespiratory
support. If acidosis is present, intravenous sodium bicarbonate must be given,
along with adequate hydration, until salicylate levels decrease to within the
therapeutic range. To enhance elimination, forced diuresis and alkalinization of
the urine may be beneficial. The need for hemoperfusion or hemodialysis is rare
and should be used only when other measures have failed.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage: 1 or 2 tablets, four
times daily.

Not recommended for use in children under age twelve (see PRECAUTIONS).

HOW SUPPLIED

Tablets containing Carisoprodol 200 mg and Aspirin 325 mg are white and light
lavender colored with double layered round shape,
unscored debossed with E724 and are available as follows

12634-438-91 UD Blister Pack

12634-438-58 Blister Pack Card of 28

12634-438-97 Bottle of 7

12634-438-84 Bottle of 14

12634-438-78 Bottle of 28

Store at controlled room temperature 15°C - 30°C (59°F - 86°F) protect from
moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).